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1 1 Assessing the Effectiveness of NeuroElectric Therapy in Reducing Acute Withdrawal Symptoms and Craving during Detoxification in Scotland Phyllis Platt, PhD, MSW- Principal Investigator and Lindsay Nelson, BA, Graduate Research Assistant Spalding University School of Social Work Louisville, KY (USA) March 2012 *Funding for this study provided by NET Device, Corp., Medford, NJ (USA)

2 2 Executive Summary Background Methadone is a widely used and well researched method of opioid detoxification. Methadone has been shown to ease the opiate withdrawal process. However, there are many downfalls to this approach to detoxification. Methadone assisted withdrawal can take between six and twenty one days and withdrawal symptoms often persist after methadone is discontinued. In addition, completion rates are quite low. The current study assesses NeuroElectric Therapy (NET) as an alternative method of opiate detoxification, specifically assessing the impact of NET on acute withdrawal symptoms and craving during detoxification and abstinence at three months posttreatment. Methods and Findings Treatment outcomes were analyzed for 104 participants who were treated at six residential facilities in Scotland using NeuroElectric Therapy (NET). Participants were drug users who tested positive for methadone or heroin at admission into a two-week residential detoxification program. Participants completed urine screens at intake and exit, completed a Withdrawal Severity Scale three times each day until discharge, and completed a urine screen at three months and six months post-treatment. Participants showed a statistically significant decrease in both craving and withdrawal symptoms from intake to exit. At 3-months post treatment, 43 eligible treatment completers were located. Twenty-six (60.4%) had a negative urine screen. Twentyeight treatment completers had been interviewed at six-months post-net. Seventeen of those (60.7%) had a negative urine screen Conclusion Compared to standard pharmaceutical assisted detoxification treatment outcomes, results for NET participates were as good or better on all treatment outcome measures. Number of days in treatment was on average eight for completers, lower than the 21 day standard treatment protocol. A retention rate of 81.7% was equivalent to or better than the 31.4%-84% rates found in the research literature. Acute withdrawal symptoms and craving were statistically significantly reduced from intake to exit for all participants. Treatment non-completers entered treatment with significantly higher craving scores which spiked on day two and resulted in high drop-out rates for those participants. At the three and six-month follow-up, the majority of program completers assessed had negative urine screens. Abstinence rates were significantly higher than the 40% rate found in the research literature. Findings from this analysis support the hypothesis that NET reduces the severity of acute withdrawal symptoms during detoxification and reduces long-term craving, both factors that support drug users ability to remain abstinent over time.

3 3 Assessing the Effectiveness of NeuroElectric Therapy in Reducing Acute Withdrawal Symptoms and Craving during Detoxification The purpose of this project was to analyze treatment data for 104 methadone and heroin users who participated in a two-week, residential detoxification program in Scotland using NeuroElectric Therapy (NET) as the primary treatment modality. Researchers were interested in determining the effectiveness of NET in reducing the severity of acute withdrawal symptoms and craving during the course of treatment. In addition, abstinence was assessed at three months and six-months using a urine screening test and self-report. Withdrawal from opioids, while not life threatening, is described as objectively mild but subjectively severe (Gossop, Griffiths, Bradley, & Strang, 1989, p. 360). Withdrawal symptoms are flu like, involving aches and pains, stomach cramps, runny eyes and nose, restlessness, hot and cold flashes, muscle spasms, and diarrhea (Bradley, Gossop, Phillips, & Legarda, 1987; Gossop, 1990; Gossop & Strang, 1991). The severity of withdrawal symptoms can lead those recovering from an opiate addiction to relapse (Bradley et al., 1987). Thus, easing the process of withdrawal may encourage further recovery and prolonged abstinence. Methadone is a widely used and researched method of opioid detoxification used to ease the opiate withdrawal process (Bearn Gossop, & Strang, 1996; Gossop & Strang, 1991; Gossop et al., 1989; Madlung-Kratzer, Spitzer, Brosch, Dunkel, & Haring, 2009). Those recovering from addiction are transferred from opioid use to methadone, and then doses of methadone are tapered and discontinued (Gossop & Strang, 1991). However, there are many downfalls to this approach of detoxification. Withdrawal with methadone can take between six and twenty one days and withdrawal symptoms persist even after methadone is discontinued (Gossop & Strang, 1991; Gossop et al., 1989; Mannelli et al., 2009). A study by Gossop and Strang (1991) found that

4 4 those withdrawing from a tapered dose of methadone have more severe withdrawal symptoms than those withdrawing from a tapered dose of heroin. Mannelli et al. (2009) found that 30.8% of participants receiving only methadone showed minimal or no improvement by the time of discharge. Retention rates for methadone assisted detoxification are generally low, ranging from 31.4% to 84% (Gowing, Ali, & White, 2000; Gossop & Strang, 1991; Bearn, Gossop, & Strang, 1996). In a review of 30 articles, Gowing, Ali & White (2000) found that the retention rate for methadone assisted withdrawal that occurred in 21 days or less is 57.5%, but over 21 days the rate is only 31.4%. The difference in retention rates for methadone assisted detoxification may be related to the pattern of withdrawal symptoms. The severity of withdrawal symptoms increases over the course of a detoxification program and peaks after the final dose of methadone (Glasper, Gossop, de Wet, Reed, & Bearn, 2007). Gossop, Griffiths, Bradley, and Strang (1989) found that in a ten day detoxification program, withdrawal scores increased from day three and did not peak until methadone was no longer administered. Similarly in a 21 day program in the same study, withdrawal symptoms increased from day ten and peaked on the final day of methadone. These researchers found that as time goes on in methadone assisted detoxification, withdrawal symptoms become more severe and more participants drop out of detoxification programs. Craving plays an important role in addiction recovery. There is a relationship between craving and substance use (Sayette et al. 2000). While some studies found a direct link between craving and relapse, other studies found that craving was not necessary to relapse. Craving has a neurological effect on motivation and inhibitory control, which can lead to an increased risk of using drugs (Sinha & Li, 2007). There are mixed results regarding the effect of methadone on craving. Fareed, Vayalapalli, Casarella, Amar, and Drexler (2010) and Mannelli et al. (2009)

5 5 found that methadone reduces craving. Mannelli et al. (2009) found a 37% decrease in craving across all groups in their study which compared methadone detoxification to a combination of methadone and naltrexone at two different doses. However, a study completed by Curran, et al (2001) found that methadone did not affect craving levels. Abstinence Within the drug treatment services arena, there is some debate about how to best define abstinence. There appears to be some variation in the definitions based on the outcomes and/or intent of the program or the drug user. Abstinence could be defined as a period of no drug use, no illegal drug use, no use of no-prescribed medication; it could be defined as involving a period ranging from weeks to months or indeed years (McKeganey et al, 2006, p. 538). Many studies describe abstinence as a period of no drug use (Cohen et al., 2005; Scherbaum & Specka, 2008; Korner & Waal, 2005; Raistrick et al., 2005). Generally, this period is simply selected by the researcher and differs for each study (Castells et al., 2009). Pharmaceutical treatment programs rarely screen for drug use at exit since abstinence is not typically defined as use of all drugs only illegal drugs (Gossip et al, 2000). When abstinence is the treatment goal, however, screenings are often conducted (McKeganey et al, 2006). NeuroElectric Therapy NeuroElectric Therapy (NET) is a form of Cranial Electrotherapy Stimulation (CES) involving electrical stimulation delivered transcranially through adhesive surface electrodes placed on the mastoid process behind the ear. The NET device itself (NET Model 901) is pocketsized allowing participants to be mobile during treatment and allowing the device to be worn 24- hours a day until treatment is complete. NET can be used to treat a variety of single and poly drug abuse combinations including amphetamines, benzodiazepines, cocaine, codeine, heroin,

6 6 methadone, methamphetamine, nicotine, and synthetic painkillers. Different drugs respond to different waveforms which allows for treatment to be tailored specifically. Stimulation is lowlevel (< 4 ma) alternating current, and the device is powered by a 9-volt battery. ScotNET Data was collected from program records for 122 participants who received NET treatment in Scotland between August 2010 and December Seven were excluded from the analysis: four tested positive for codeine, two tested positive for Suboxone, and one had no recorded WSS scores. Eleven duplicate cases were excluded. First admission data was maintained for these eleven participants. After data cleaning, 104 records were utilized in the data analysis. Entry into and continuation of treatment was voluntary for all participants. Participants received services at six residential treatment facilities. These facilities were regulated by the Care Commission and met the Scottish Government's National Care Standards. Participants were both male and female. Measures The Withdrawal Severity Scale (WSS) was used to assess acute withdrawal symptoms three times daily: morning, noon, and evening. The WSS utilizes a four point Likert rating {0- none, 1-mild, 2-moderate, 3-severe} to assess severity of symptoms. A composite score is calculated by adding the severity scores for each symptom. The WSS is compatible with the Subjective Opiate Withdrawal Scale (SOWS) and the shortened version of this scale, standardized measures utilized widely in substance abuse treatment research. The Subjective Opiate Withdrawal scale, developed by Handelsman et al. (1987) is a 16-item self-report scale measuring the presence and intensity of opiate withdrawal symptoms. Each symptom is scored from 0 to 4 (0= not at all, 1=a little, 2=moderately, 3=quite a bit, 4= extremely). This scale has

7 7 been shown have a moderate degree of test-retest reliability (0.60; p < 0.001) and good construct validity. The Short Opiate Withdrawal scale, developed by Gossop (1990) is a 10-item self-report scale measuring the presence and intensity of opiate withdrawal symptoms on a scale of 0 to3 (0=None, 1=Mild, 2= Moderate, 3=Severe). This measure has been shown to be both reliable and valid. Table 1 displays a comparison of the symptoms measured in the Subjective and Short Opiate Withdrawal Scales and the WSS. Table 1 Comparison of the Withdrawal Severity Scale to the Subjective Opiate Withdrawal Scale and the Short Opiate Withdrawal Scale Withdrawal Severity Scale Short Opiate Withdrawal Subjective Opiate Withdrawal Scale Scale Agitation/Restlessness Aches and pains I feel restless Body Aches/Pains My bones and muscles ache Chills Feelings of coldness I have cold flashes Craving I feel like (using) now Diarrhea Feeling Sick Feeling Down/Depressed Feelings of Unreality Head/Body/Hand Tremors Muscular tension My muscles twitch Headache Irritable/Nervous I feel anxious Low Energy/Fatigue Nausea/Vomiting I feel nauseous I feel like vomiting Palpitations/Pounding Heart Heart pounding Poor Concentration Shakiness Muscle spasms/twitching I am shaking Stomach Cramps Stomach Cramps I have cramps in my stomach Suspicious/Paranoid Sweating I m perspiring Teary Eyes/Runny Nose Runny Eyes My eyes are tearing My nose is running Tingling in Fingers/Toes Unsteadiness/Feelings of Motion Visual Disturbances Insomnia/Problems Sleeping Yawning I feel like yawning I have goose flesh I have hot flashes

8 8 Craving was measured by one question on the WSS asking participants to rate severity at the time of assessment. Abstinence was measured at the three and six-month follow up by a urine or oral fluid screening test. Self-report was accepted for drug use at three and six-month followup; however, self-report was not accepted for abstinence. Results Participants All of the 104 participants were residents of Scotland who entered treatment voluntarily. Seventy-two (69.2%) of participants were male and 32 (30.8%) were female. Participants ranged in age from 24 years to 51 years with an average age of 37. Length of drug use prior to entering NET treatment ranged from 2 to 32 years with an average length of drug use of 16 years. Overall, at intake 64.4% of participants tested positive on a urine screen for Methadone, 65.4% tested positive for heroin. Thirty percent (30%) tested positive for both Methadone and heroin. When drug use was examined by gender, 62.5% of men and 68.8% of women tested positive for Methadone; 73.6% of men and 46.9% of women tested positive for heroin. More than twice as many men than women tested positive for both, 36.1% compared to 15.6%. Fiftyfour percent of all participants (n=56) received treatment for benzodiazepine abuse in addition to opioid abuse. Acute Withdrawal Symptoms At intake and prior to beginning NET, the average WSS score for all participants was (N=104, SD= 12.32). At exit (including those who completed NET treatment and those who did not), the average WSS score was 7.80 (N=104; SD=10.96). There was a statistically significant difference between WSS scores for all participants from intake to exit (t=15.59; df=103; p<.001). Figure 1 compares the average daily WSS scores for those who completed and

9 WSS Score 9 those who did not complete NET detoxification. At exit from NET, treatment completers had an average WSS score of 4.36 (n=85), whereas non-completers had an average score of (n=19). Figure 1 Comparison of Withdrawal Symptoms for NET Treatment Completers and Non-Completers n=19 n=3 n= n=85 n=7 n=85 n=19 n=84 n=84 n=78 n=2 n=1 n=64 n=44 n=55 n=32 n=25 n=17 n=10 n=7 n=5 Non Completers Completers Day Craving At intake, craving intensity was assessed for all participants using a single question on the WSS. Scores had a possible ranking of 0 to 3 with 0 indicating no craving. The average craving score at intake for all participants was 1.52 (N=104). Non-completers reported higher craving scores on average at intake (2.16) compared to completers (1.38). At exit, the average score for all participants was.31 (N=104). All participants reported a statistically significant reduction in craving (t=11.11; df=103; p<.001) from intake to exit.

10 Craving Score 10 The average craving score at exit for completers was.08 (N=85) and the average craving score for non-completers was 1.32 (N=19).Figure 2 compares the average daily craving scores for those who completed and those who did not complete NET detoxification. At exit, there was a statistically significant difference between craving scores for completers and non-completers (t=8.354; df=102; p<.001). Figure 2 Comparison of Craving Scores during NET Treatment for Program Completers and Noncompleters n=19 n=7 n= n=19 n=3 n=2 n=1 0.8 n=85 n= n= n=84 n=10 n=7 n=64 n=44 n= n=78 n=55 n=32 n= n=5 Day Non-Completers Completers Treatment Completion The Scotland NET detoxification program had a completion rate of 81.7% (n=85). There were no statistically significant differences among participants for treatment completion by gender. Eighty-two percent of males (n=59) and eighty-one percent of females (n=26)

11 11 completed treatment. No significant differences were found for treatment among participants at intake by age, length of drug use prior to intake, or WSS scores at intake (see Table 2). Ninety percent (n=17) of non-completers tested positive for heroin at intake. Thirtyseven percent of non-completers (n=7) tested positive for methadone and heroin. Twenty-six percent (n=5) of non-completers were among the group that also tested positive for benzodiazepine at intake into treatment. For all participants, the number of days in treatment ranged from two to 14 days, and the average number of days in treatment was seven (SD=3.28). Those who completed NET treatment averaged about eight days in treatment (SD=2.81) and those who did not complete treatment averaged about 3 days in treatment (SD=1.44). Completion rates across all six residential facilities ranged from 70.8%-100%. Table 2. Comparison of Completers and Non-Completers at Intake Completed N Mean SD NET Age No Yes Length of Drug Use No Yes WSS-Intake No Yes Craving-Intake* No Yes *Differences statistically significant at p<.01

12 12 Post-treatment, 3-month and 6-month Follow-up For non-completers a urine screen was collected at exit when possible. All five noncompleters tested had positive urine screens at exit. Urine screens were available for 74 of the treatment completers. Sixty-six (89.2%) tested negative for opiates at exit. Seventy-three treatment completers (89%) were eligible for 3-month follow up interviews at the time records were reviewed for analysis. Program staff was unable to locate thirty (41%) of the eligible completers. Follow-up interviews were conducted with 43 treatment completers. Of those interviewed, twenty-six (60.4%) had a negative urine screen. Fifteen (34.8%) self-reported positive drug use at the 3-month interview. Four non-completers interviewed reported positive drug use. Twenty-eight treatment completers had been interviewed at six-months post-net. Seventeen of those (60.7%) had negative urine tests. Eleven (39.2%) self-reported drug use. Conclusions A comparison between the use of NET as a primary treatment modality and the use of pharmaceutical assisted detoxification indicates that participants in the ScotNET program fared as well or better than their counterparts on treatment outcome variables. The average number of days in treatment for program completers was eight, significantly lower than the standard 21 day treatment protocol (Gowing, Ali & White, 2000). The ScotNET treatment program had a completion rate of 81.7%. This rate is comparable to the higher retention rates found by Bearn, Gossop, and Strang (1998), Gossop and Strang (1991) both of which had completion rates of 84%. It is much higher than retention rate of 57.5% for programs lasting less than 21 days identified in a review of 30 research articles (Gowing, Ali & White, 2000).

13 13 Withdrawal symptoms for all participants declined significantly from intake to exit from treatment. Unlike with methadone assisted detoxification, NET withdrawal symptom scores peaked on day two. Withdrawal symptoms declined steadily during treatment. WSS scores decreased significantly for both program completers and non-completers. Non-completers withdrawal severity scores rose dramatically on day two then declined but never returned to intake levels. However, withdrawal scores for those who completed NET treatment continued to decline below intake levels. Findings from this study support the hypothesis that NET treatment reduces acute withdrawal symptoms during detoxification. Craving scores significantly decreased for all participants from intake to exit from treatment. Craving scores decreased by 79.6% in this study. This decrease in craving is much greater than the 37% decrease found by Mannelli et al. (2009). These findings support the hypothesis that NET reduces drug craving. Although craving scores dropped steadily from intake for treatment completers, noncompleters entered treatment with higher average craving scores. Craving scores and WSS scores rose for non-completers on day two resulting in a high drop-out rate at this point in treatment. As noted in the research literature, craving has a neurological effect on motivation and inhibitory control (Sinha & Li, 2007). Further research is needed to better understand factors that may be contributing to the spike in craving and withdrawal symptom severity on day two for non-completers. Treatment staff may need to target additional supports to these participants to mitigate the impact of craving on motivation to remain in treatment. The 89.2% rate of treatment completers who were opiate free at exit is much higher than the 24.4% rate found by other researchers using brief pharmacological detox methods (Raistrick et al, 2005). Rates for long term abstinence from drug use were also significant among program

14 14 completers at 60.4%. This rate is higher than the 40% rate for heroin users found in other studies (Gossop, Stewart, Browne, & Marsden, 2002). The reduction in craving appears to strongly impact abstinence rates and warrants further study. Limitations It is important to understand the limitations of this study when considering the generalizability of results. The lack of comparison or control groups may be considered a limiting factor when attributing changes to NET. However, the assessment of efficacy using quantitative comparisons to evidence-based practices, interventions for which there is consistent scientific evidence showing that they improve client outcomes (Drake, et al, 2001, para. 11) increases the validity of results. A second limitation is the lack of established reliability and validity of the Withdrawal Severity Scale. It is evident from the comparison to the SOWS that the WSS does include the majority of symptoms. However, further research should be conducted to establish the WSS as a reliable and valid measure. Practitioners might also consider adoption of the SOWS as the standardized measure for assessing withdrawal symptoms. Despite these study limitations, the reduction of acute withdrawal symptoms and craving as well as the evidence of prolonged abstinence among a high percentage of program completers support the hypothesis that NET is an effective treatment modality for addressing acute withdrawal symptoms and long-term craving.

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